Effects of a Physical Rehabilitation Program Using the Nintendo Wii on Children With Osteogenesis Imperfecta (OI)

Effects of a Physical Rehabilitation Program Using the Nintendo Wii on Children With Osteogenesis Imperfecta (OI) Is Nintendo Wii an Effective Intervention for Children With Osteogenesis Imperfecta

Children with osteogenesis imperfecta are described as extremely sedentary and therefore fatigable, which strongly impacts their daily activities. The physical rehabilitation of these children is a fundamental aspect of treatment.

It has been shown that playing Wii console causes the same increase in energy expenditure than practicing moderate exercise, while ensuring user safety. This type of physical exercise with this type of fun game console might have a role in the treatment of OI children on the physical side but also on the psychological side.

Study Overview

• Status: Terminated
• Conditions: Osteogenesis Imperfecta
• Intervention / Treatment: Other: Training with Nintendo Wii console

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Etienne, France, 42055
    • Chu Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• - Children affiliated to a social security scheme
• Children diagnosed OI by a competent physician of one of the French specialist centers;
• OI children type 1 or type 4;
• Stable OI (far from a fractional episode of at least two months);
• Children without regular activity on the Nintendo Wii console or other interactive console;
• Boy or Girl> 6 to 18 years
• Parents or person having parental authority affiliated to a social security scheme
• Parents or person having parental authority who signed the consent form for the study.

Exclusion Criteria:

• - Children who can not walk;
• Children with severe OI other than type 1 or type 4;
• Fracture during the last two months;
• Surgical intervention within the last 8 months;
• Inability to understand and follow the protocol;
• Participation in another clinical study;
• Children, parents or holder of parental authority refusing the written consent.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OI Children training with Nintendo Wii console; Training for 3 months using the Nintendo Wii console on physical capacity in a group of children with Osteogenesis Imperfecta	Other: Training with Nintendo Wii console; Children with OI and draining for 3 months using Nintendo Wii console
No Intervention: Children with OI without training; No training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in physical capacity	Compare the change in physical capacity between training group of children with OI and control group of children with OI. The physical capacity is measured by maximal oxygen consumption VO2 max (ml/min/kg) measured during incremental exercise on cycle ergometer	from baseline to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in physical capacity	Compare the change in physical capacity between training group of children with OI and control group of children with OI. The physical capacity is measured by maximal oxygen consumption VO2 max (ml/min/kg) measured during incremental exercise on cycle ergometer	From baseline to 9 months
Compare physical inactivity between training group and control group	Physical inactivity will be assessed by the Physical Activity Questionnaire (Q-APS)	Month 3
Compare physical inactivity between training group and control group	Physical inactivity will be assessed by the Physical Activity Questionnaire (Q-APS)	Month 9
Compare functional benefit between training group and control group	The functional benefit will be evaluated by the Functional Independence Measure (FIM)	Month 3
Compare functional benefit between training group and control group	The functional benefit will be evaluated by the Functional Independence Measure (FIM)	Month 9
Compare body fat between training group and control group	Body fat composition will be determined by skinfold measurements	Month 3
Compare body fat between training group and control group	Body fat composition will be determined by skinfold measurements	Month 9
Compare quality of life between training group and control group	The quality of life will be determined the Index Questionnaire Reintegration to Normal Life (IRVN)	Month 3
Compare quality of life between training group and control group	The quality of life will be determined the Index Questionnaire Reintegration to Normal Life (IRVN)	Month 9
Compare muscle strength between training group and control group	The muscle strength is a composite outcome. It will be assessed by: The grip strength (force applied by the hand); The maximal quadriceps muscle strength will be measured using an isokinetic dynamometer "Contrex"	Month 3
Compare muscle strength between training group and control group	The muscle strength is a composite outcome. It will be assessed by: The grip strength (force applied by the hand); The maximal quadriceps muscle strength will be measured using an isokinetic dynamometer "Contrex"	Month 9
Compare endurance of lower limbs between training group and control group	The endurance of the lower limbs will be measured by EMG analysis on incremental torque repetitive exercise	Month 3
Compare endurance of lower limbs between training group and control group	The endurance of the lower limbs will be measured by EMG analysis on incremental torque repetitive exercise	Month 9
Compare Energy expenditure of lower limbs between training group and control group	Energy expenditure is a composite outcome. It will be measured by collecting the respiratory exchange and heart rate during endurance, tennis and boxing games using the Nintendo WII	Month 3
Compare Energy expenditure of lower limbs between training group and control group	Energy expenditure is a composite outcome. It will be measured by collecting the respiratory exchange and heart rate during endurance, tennis and boxing games using the Nintendo WII	Month 9
Training tolerance	Reentrainment tolerance is a composite outcome. It will be assessed by : collecting any events related to WII training or any events related to everyday life (fractures, pain,etc.); dropout rate study report	Baseline from 9 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Fondation de France
• Investigators: Principal Investigator: Vincent GAUTHERON, PhD, Chu Saint-Etienne

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: September 3, 2015
• First Submitted That Met QC Criteria: September 4, 2015
• First Posted (Estimate): September 7, 2015

Study Record Updates

• Last Update Posted (Estimate): January 20, 2016
• Last Update Submitted That Met QC Criteria: January 19, 2016
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Osteogenesis Imperfecta; muscular strength; Wii; physical exercise training
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Musculoskeletal Diseases; Connective Tissue Diseases; Bone Diseases; Bone Diseases, Developmental; Osteochondrodysplasias; Collagen Diseases; Osteogenesis Imperfecta
• Other Study ID Numbers: 1201174